Globe Clotrimazole Cream Usp, 1%

Globe Clotrimazole Cream Usp, 1%
SPL v5
SPL
SPL Set ID e0a2a907-9c3a-4c4e-e053-2995a90abb91
Route
TOPICAL
Published
Effective Date 2022-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Light Mineral Oil Petrolatum Water Ceteth-20 Propylparaben Cetostearyl Alcohol Methylparaben Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-08

Description

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream


Medication Information

Purpose

Antifungal Cream

Description

Clotrimazole USP 1% w/w

Uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Section 50565-1

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Warnings

Do not use on children under 2 years of age unless directed by a doctor.

● For external use only

● Avoid contact with eyes.

Packaging

Directions
  • Wash the affected area and dry thoroughly.

● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.

● Supervise children in the use of this product.

● For athlete’s foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

● If conditions persists longer, consult a doctor.

● This product is not effective on the scalp or nails. 

Questions?

Adverse drug event call 1-888-296-9067



Dist. By Trifecta Pharmaceuticals USA™



101 NE Third Avenue, Suite 1500



Ft. Lauderdale, FL 33301, USA

Made in India

www.trifecta-pharma.com

Globe Clotrimazole Anti-Fungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin AF.

Active Ingredient

Clotrimazole USP 1% w/w

Other Information
  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.
Inactive Ingredients

Cetamacragol 1000, Cetostearyl alcohol, mineral oil, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum.

Stop Use and Ask A Doctor

Irritation occurs

There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).


Structured Label Content

Uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Purpose

Antifungal Cream

Warnings

Do not use on children under 2 years of age unless directed by a doctor.

● For external use only

● Avoid contact with eyes.

Packaging

Directions
  • Wash the affected area and dry thoroughly.

● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.

● Supervise children in the use of this product.

● For athlete’s foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

● If conditions persists longer, consult a doctor.

● This product is not effective on the scalp or nails. 

Questions?

Adverse drug event call 1-888-296-9067



Dist. By Trifecta Pharmaceuticals USA™



101 NE Third Avenue, Suite 1500



Ft. Lauderdale, FL 33301, USA

Made in India

www.trifecta-pharma.com

Globe Clotrimazole Anti-Fungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin AF.

Active Ingredient (Active ingredient)

Clotrimazole USP 1% w/w

Other Information
  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.
Inactive Ingredients

Cetamacragol 1000, Cetostearyl alcohol, mineral oil, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum.

Stop Use and Ask A Doctor (Stop Use and ask a Doctor)

Irritation occurs

There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).


Advanced Ingredient Data


Raw Label Data

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